Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control?
- Thomas Hardy, MD, PHD1,
- Richard Sachson, MD2,
- Shuyi Shen, PHD1,
- Mary Armbruster, MSN, CDE1 and
- Andrew J.M. Boulton, MD, FRCP34
- 1Eli Lilly, Indianapolis, Indiana
- 2Department of Internal Medicine, Southwestern Medical Center, University of Texas, Dallas, Texas
- 3Division of Endocrinology, Metabolism, and Diabetes, University of Miami School of Medicine, Miami, Florida
- 4University Department of Medicine, Manchester Royal Infirmary, Manchester, U.K.
- Address correspondence and reprint requests to Thomas Hardy, MD, PhD, Eli Lilly, Lilly Corporate Center DC 2138, Indianapolis, IN 46285. E-mail: hardyta{at}lilly.com
Abstract
OBJECTIVE—We examined changes in metabolic parameters in clinical trials of duloxetine for diabetic peripheral neuropathic pain (DPNP).
RESEARCH DESIGN AND METHODS—Data were pooled from three similarly designed clinical trials. Adults with diabetes and DPNP (n = 1,024) were randomized to 60 mg duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n = 867) were re-randomized to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to identify relationships between metabolic measures and demographic, clinical, and electrophysiological parameters.
RESULTS—Duloxetine treatment resulted in modest increases in fasting plasma glucose in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). A1C did not increase in placebo-controlled studies; however, a greater increase was seen relative to routine care in long-term studies (0.52 vs. 0.19%). Short-term duloxetine treatment resulted in mean weight loss (−1.03 kg; P < 0.001 vs. placebo), whereas slight, nonsignificant weight gain was seen in both duloxetine and routine care groups with longer treatment. Between-group differences were seen for some lipid parameters, but these changes were generally small. Metabolic changes did not appear to impact improvement in pain severity seen with duloxetine, and nerve conduction was also not significantly impacted by treatment.
CONCLUSIONS—Duloxetine treatment was associated with modest changes in glycemia in patients with DPNP. Other metabolic changes were limited and of uncertain significance. These changes did not impact the significant improvement in pain observed with duloxetine treatment.
- BPI, brief pain inventory
- DPN, diabetic peripheral neuropathy
- DPNP, DPN pain
- FPG, fasting plasma glucose
- TCA, tricyclic antidepressant
Footnotes
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R.S. has received research grants from and has been a speaker for Eli Lilly. A.J.M.B. serves on an advisory panel for Eli Lilly.
Data from this study were previously published in abstract form in 2004, specifically as “The safety of duloxetine in the long-term treatment of diabetic neuropathic pain” at the 20th Annual Meeting of the American Academy of Pain Medicine in Orlando, Florida, and as “Duloxetine at doses of 60 mg QD and 60 mg BID is effective treatment of diabetic neuropathic pain” at the 56th Annual Meeting of the American Academy of Neurology in San Francisco, California.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
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- Accepted September 29, 2006.
- Received May 10, 2006.
- DIABETES CARE
